EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer

NCT05086705 | Completed Results DMC FDA Device

• 2 other identifiers: OSU-19152NCI-2019-05843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.

Conditions

Breast Carcinoma; Breast Ductal Carcinoma In Situ; Breast Lobular Carcinoma In Situ; Hot Flashes

Outcome Measures

Primary Outcomes (2)

• Device Usage

  Feasibility will be evaluated primarily with respect to device usage. The proportion of patients who wear the device for at least 8 hours between 8:00 am and 8:00 pm for at least 22 days will be estimated using the entire sample and a 95% Jeffreys interval for binomial proportions will be computed.

  Up to 8 weeks

• Patient Satisfaction

  Feasibility will be evaluated secondarily with respect to patient satisfaction. The mean patient satisfaction scores for each Likert-type question and proportion of patients reporting satisfaction scores at or above 7 will be estimated in the entire sample and compared between sequence groups at the 5% significance level (two-sided).Rated on a 10-point Likert scale with 10 being most satisfied or most effective.

  At 8 weeks

Secondary Outcomes (1)

• Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)

  At week 4 and at week 8

Study Arms (2)

Arm A (EMBr Wave)

EXPERIMENTAL

Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks.

Device: EMBr Wave; Other: Questionnaire Administration

Arm B (crossover)

ACTIVE COMPARATOR

Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.

Device: EMBr Wave; Other: Questionnaire Administration

Interventions

EMBr Wave DEVICE

Use EMBr Wave

Arm A (EMBr Wave); Arm B (crossover)

Questionnaire Administration OTHER

Ancillary studies

Arm A (EMBr Wave); Arm B (crossover)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with history of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular breast carcinoma in situ (LCIS) (currently without evidence of malignant disease)
• Bothersome hot flashes (defined by their occurrence of \>= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention)
• Presence of hot flashes for \> 30 days prior to study entry
• Ability to complete questionnaire(s) by themselves or with assistance
• Willingness to wear EMBr Wave device during the study period
• Willingness to use the EMBr Wave mobile application
• Have a working smartphone that can download the EMBr Wave mobile application (iPhone 6 or more recent generation, Android 8.0 or more recent generation)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1
• Ability to provide informed written consent
• Life expectancy \>= 6 months

You may not qualify if:

• Antineoplastic chemotherapy (anti-HER2 agents allowed) (current \[=\< 4 weeks prior\] or planned therapy)
• Androgens (current \[=\< 4 weeks prior\] or planned therapy)
• Systemic estrogens. Local vaginal estrogen preparations are allowed, but need to have been initiated for vulvo-vaginal atrophy at least 28 days prior, and must not be expected to stop or change the dose or frequency of the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy)
• Progestogens (current \[=\< 4 weeks prior\] or planned therapy)
• Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy)
• Selective serotonin reuptate inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitor (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration (current \[=\< 4 weeks prior\] or planned therapy)
• Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration) (current \[=\< 4 weeks prior\] or planned therapy)
• Clonidine (current \[=\< 4 weeks prior\] or planned therapy)
• Prior use of EMBr Wave
• Nickel allergy
• Pregnant or nursing women since the safety of device has not been established in this population

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Embr Labs, Inc.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Hot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sagar Sardesai
• Organization: The Ohio State University Comprehensive Cancer Center

sagar.sardesai@osumc.edu

614-293-6401

Study Officials

• Sagar Sardesai, MBBS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: October 7, 2020
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)